NCT04245865Active, not recruitingPhase 2
Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer
Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer. A Randomized Phase II Marker Trial
Source: ClinicalTrials.gov · Last updated 3 Apr 2026
Brief summary (registry, in English)
This double blind, randomized phase II trial will investigate whether the addition of tocotrienol will improve the effect and lower the toxicity of standard chemotherapy and bevacizumab. Half of the patients will receive tocotrienol and the other half placebo. Treatment is planned for a period of maximum six months and will be discontinued earlier in case of progression or unacceptable toxicity.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 83 (actual)
- First submitted
- 27 Jan 2020
- Start date
- 26 Jun 2020
- Primary completion date
- 31 Mar 2025
- Lead sponsor
- Vejle Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT04245865
- EU CT number
- 2024-517075-21-00
- EudraCT number
- 2019-004207-13
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 83
- From 26 Jun 2020 to the primary completion date, 31 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other active malignant disease within 5 years prior to inclusion in the study.
- Other experimental therapy within 28 days prior to treatment initiation.
- Surgery, including open biopsy, within 4 weeks prior to first dose of bevacizumab.
- Cerebral vascular attack, transient ischemic attack or subarachnoid hemorrhage within six months before start of treatment
Other illness
- Underlying medical disease not adequately treated.
- Bleeding tumor
- Hypersensitivity to one or more active substances or auxiliary substances
Other
- Pregnant or breastfeeding women
- Fertile patients not willing to use effective methods of contraception during treatment and for six months after end of treatment.
Who the study is looking for
- Histopathologically verified adenocarcinoma of the colon or rectum
- Metastatic disease
- Planned treatment with FOLFOX or capecitabine combined with bevacizumab
- Evaluable disease according to RECIST 1.1
- Performance status 0-2
- Expected survival ≥ 3 months
- Patient acceptance to collection of blood samples for translational research
- Age ≥ 18 years
- Contraception during and 6 months after last dose for women of childbearing potential (less than one year amenorrhea and not undergone hysterectomy, bilateral salpingectomy or bilateral oophorectomy) and for male patients with a fertile partner. Hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence is accepted.
- Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):
- WBC ≥ 3.0 x 109/l or neutrophils (ANC) ≥ 1.5 x 10\^9/l
- Platelet count ≥ 100 x 10\^9/l
- Hemoglobin ≥ 6.0 mmol/l
- Serum bilirubin ≤ 2.0 x ULN
- Serum transaminase ≤ 2.5 x ULN
- Serum creatinine ≤ 1.5 ULN
- Urine dipstick for protein ≤ 2+, if the dipstick shows protein ≥ 2+, 24 hour urine testing must be performed and show protein contents ≤ 1g.
- Written and orally informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lillebaelt Hospital Coordinator of this site? Confirm its status | Vejle | Denmark | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.